BJORK-SHILEY AORTIC GRAFT VALVE PROSTH

BJORK-SHILEY AORTIC GRAFT VALVE PROSTH is an FDA 510(k)-cleared medical device (K791225) manufactured by Shiley, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on August 9, 1979. Regulation: 8.